Temozolomide With or Without Capecitabine in Treating Patients With Advanced Pancreatic Neuroendocrine Tumors

This study is ongoing, but not recruiting participants.

Sponsor:

Eastern Cooperative Oncology Group

ClinicalTrials.gov Identifier:

NCT01824875

First Posted: April 5, 2013

Last Update Posted: March 9, 2016

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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This randomized phase II trial studies how well giving temozolomide with or without capecitabine works in treating patients with advanced pancreatic neuroendocrine tumors. Drugs used in chemotherapy, such as temozolomide and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether temozolomide is more effective with or without capecitabine in treating patients with advanced pancreatic neuroendocrine tumors.

Further study details as provided by Eastern Cooperative Oncology Group:

Primary Outcome Measures:

PFS [ Time Frame: Up to 5 years ]

Secondary Outcome Measures:

RR defined by revised RECIST criteria version 1.1 [ Time Frame: Up to 5 years ]

Compared between arms using a two-group Fisher's exact test at an overall two-sided 20% significance level. In addition, within each arm, a 90% confidence interval on the true objective response rate will be no wider than 21 percentage points.

Overall survival [ Time Frame: Up to 5 years ]

Toxicity rates using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 [ Time Frame: Up to 5 years ]

Patients receive temozolomide PO QD on days 1-5. Treatment repeats every 28 days for up to 13 courses in the absence of disease progression or unacceptable toxicity.

Drug: temozolomide

Given PO

Other Names:

SCH 52365

Temodal

Temodar

TMZ

Other: laboratory biomarker analysis

Correlative studies

Experimental: Arm B (temozolomide and capecitabine)

Patients receive capecitabine PO BID on days 1-14 and temozolomide PO QD on days 10-14. Treatment repeats every 28 days for up to 13 courses in the absence of disease progression or unacceptable toxicity.

ARM A: Patients receive temozolomide orally (PO) once daily (QD) on days 1-5. Treatment repeats every 28 days for up to 13 courses in the absence of disease progression or unacceptable toxicity.

ARM B: Patients receive capecitabine PO twice daily (BID) on days 1-14 and temozolomide PO QD on days 10-14. Treatment repeats every 28 days for up to 13 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for 2 years, and then every 6 months for 3 years.

Eligibility

Information from the National Library of Medicine

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Patient must have measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria; baseline measurements and evaluations of all sites of disease must be obtained =< 4 weeks prior to randomization and must be acquired by multiphasic CT or contrast magnetic resonance imaging (MRI)

Date of last documented disease progression must be =< 12 months from date of randomization

Patient must not have received prior temozolomide, dacarbazine (DTIC), or capecitabine, or 5-FU (fluorouracil) therapy

Prior everolimus and/or sunitinib therapy is allowed, so long as it was discontinued >= 4 weeks prior to randomization

Concurrent somatostatin analogues are allowed provided that patients

Have been on stable doses for 8 weeks and

Have documented disease progression on that dose

Patients may not be receiving any other investigational agents while on study treatment

Patients may not be receiving Coumadin while on treatment; other anticoagulants are allowed

Patients with either clinically apparent central nervous system metastases or carcinomatous meningitis are ineligible

Patients must NOT have active or uncontrolled infection or serious medical or psychiatric illness

Patients must NOT have history of allergic reactions attributed to compounds of similar chemical or biologic composition to temozolomide or capecitabine

Patient must NOT have absorption issues that would limit the ability to absorb study agents

Patients with a history of the following within =< 12 months of study entry are not eligible:

Arterial thromboembolic events

Unstable angina

Myocardial Infarction

Patients with symptomatic peripheral vascular disease are not eligible

Patients must NOT have previous or concurrent malignancy; exceptions are made for patients who meet any of the following conditions:

Non-melanoma skin cancer, in situ cervical cancer, or breast cancer in situ OR

Prior malignancy completely excised or removed and patient has been continuously disease free for > 5 years OR

Prior malignancy cured by non-surgical modalities and patient has been continuously disease free for > 5 years

Women must not be pregnant or breast-feeding; all females of childbearing potential must have a blood test or urine study within =< 2 weeks prior to randomization to rule out pregnancy; a female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria:

Has not undergone a hysterectomy or bilateral oophorectomy; or

Has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)

Women of childbearing potential and sexually active males must be strongly advised to use an accepted and effective method of contraception or to abstain from sexual intercourse for the duration of their participation in the study; should a woman become pregnant while participating in this study, she should inform her treating physician immediately; if a man impregnates a woman while participating in this study, he should inform his treating physician immediately

Patient must be able to swallow pills

Patient must be able to tolerate CT or magnetic resonance (MR) imaging including contrast agents as required for their treatment and the protocol

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01824875